BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1990681 · Received February 8, 2011

    Report

    Report Number
    2024601-2011-00094
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 15, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE, NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. NECROSIS, OBSTRUCTION, BAND SLIPPAGE, POUCH DILATION, ABDOMINAL PAIN, HERNIA, NAUSEA, AND VOMIT ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF OBSTRUCTION AS FOLLOWS: "OBSTRUCTION OF STOMAS HAS BEEN REPORTED AS BOTH AN EARLY AND A LATE COMPLICATION OF THIS PROCEDURE. THIS CAN BE CAUSED BY EDEMA, FOOD, IMPROPER INITIAL CALIBRATION, BAND SLIPPAGE, POUCH TORSION, OR PT NONCOMPLIANCE REGARDING CHOICE AND CHEWING OF FOOD." "PTS MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PTS WITH DENTURES MUST BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." "IF THERE IS TOTAL STOMAL OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION, OR IF THERE IS ABDOMINAL PAIN, THEN IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF BAND SLIPPAGE AND POUCH DILATION AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR." "OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." "GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL." "FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ABDOMINAL PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION..." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF NAUSEA AND VOMIT AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED. NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE."

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENTS OF "NECROTIZING ULCERATION OF THE FUNDUS", "GASTRIC OUTLET OBSTRUCTION", "SLIPPED LAP BAND", "DILATED PROXIMAL STOMACH WITH HERNIATION", "ABDOMINAL PAIN", NAUSEA, AND VOMITING FROM ABSTRACT ENTITLED, "MIGRATION OF ADJUSTABLE GASTRIC BANDING RESULTING IN SPLENIC INFARCTION AND NECROTIZING GASTRIC ULCERATION: A CASE REPORT", THE AMERICAN JOURNAL OF GASTROENTEROLOGY (2010) NO. 477, VOL. 105, SUPP. 1, PAGE S174. FOLLOW-UP INFORMATION: DOCTOR REPORTED TYPE OF BAND UNK AND DID NOT ABSOLVE THE DEVICE. IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R